Extra Strength Headache
- Manufacturer
- Lil' Drug Store Products, Inc.
- Effective date
- 2024-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:50:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purposes
Pain reliever
Pain reliever
Pain reliever aid
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- sinusitis
- toothache
- premenstrual and menstrual cramps
WARNINGS SECTION
Reye's Syndrome
Reye’s syndrome: Children and teenagers who have or are
recovering from chicken pox or flu-like symptoms should not
use this product. When using this product, if changes in
behavior with nausea and vomiting occur, consult a doctor
because these symptoms could be an early sign of Reye's
syndrome, a rare but serious illness.
Allergy Alert
Allergy alert:Aspirin may cause a severe allergic reaction,
which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Allergy Alert
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take: • more than 8 caplets
in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The
chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Caffeine warning
Caffeine warning: The recommended dose of this product
contains about as much caffeine as a cup of coffee. Limit
the use of caffeine-containing medications, foods, or
beverages while taking this product because too much
caffeine may cause nervousness, irritability, sleeplessness,
and, occasionally, rapid heartbeat.
OTC - DO NOT USE SECTION
Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
- you have liver disease
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking
- any other drug containing an NSAID (prescription or nonprescription)
- a prescription drug for diabetes, gout, or arthritis
- any other drug or are under a doctor’s care for any serious condition
- a blood thinning (anticoagulant) or steroid drug
OTC - STOP USE SECTION
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms appear
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional
before use. It is especially important not to use aspirin
during the last 3 months of pregnancy unless definitely
directed to do so by a doctor because it may cause problems
in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
Overdose warning: In case of overdose, get medical help
or contact a Poison Control Center right away
(1-800-222-1222). Quick medical attention is critical for
adults as well as for children even if you do not notice any
signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not use more than directed (see Overdose warning)
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
Other information
- store between 20°-25°C (68°-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc
OTC - QUESTIONS SECTION
Questions or comments?
Call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)
PDP (Lil' Drug)
[caduceus]
Compare to the Active
Ingredients in Excedrin®
Extra Strength**
Extra Strength
Headache
Acetaminophen 250 mg
Pain Reliever
Aspirin (NSAID) 250 mg Pain Reliever
Caffeine 65 mg Pain Reliever Aid
[caplets image]
ACTUAL SIZE
50
Caplets [Lil' Drug Store Logo]
PDP (CK)
TEMPORARILY RELIEVES
HEADACHES
Compare to the active ingredients
in
Excedrin
® Extra Strength*
CIRCLE K™
extra strength
headache
Acetaminophen 250 mg, Pain Reliever
Aspirin (NSAID) 250 mg, Pain Reliever
Caffeine 65 mg, Pain Reliever Aid
[caplet image]
actual size
50 caplets
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66715-5506-4 | Extra Strength Headache, Circle K | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 66715-5506-4 | Extra Strength Headache, Circle K | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 5 | |
| 66715-6922-4 | Extra Strength Headache | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 66715-6922-4 | Extra Strength Headache | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66715-5506 | EXTRA STRENGTH HEADACHE, CIRCLE K (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET EXTRA STRENGTH HEADACHE (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250101_d18e1631-de43-4b29-e053-2995a90af56d.zip |
| 66715-6922 | EXTRA STRENGTH HEADACHE, CIRCLE K (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET EXTRA STRENGTH HEADACHE (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250101_d18e1631-de43-4b29-e053-2995a90af56d.zip |
Products#
Every source-derived product name is available through these pages.
- Extra Strength Headache, Circle K
- acetaminophen/aspirin/caffeine tablet
- TALC
- ASPIRIN
- CAFFEINE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE K30
- HYPROMELLOSE, UNSPECIFIED
- ACETAMINOPHEN
- STARCH, CORN
- STEARIC ACID
- SILICON DIOXIDE
- Extra Strength Headache
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-5506 | 66715-5506-4 |
| 68210-4094 | |
| 66715-6922 | 66715-6922-4 |
| 68210-0107 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Extra Strength Headache, Circle K | ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET | Lil' Drug Store Products, Inc. | d18e1631-de43-4b29-e053-2995a90af56d | 2024-12-31 | Warnings | 66715-6922-4 66715-5506-4 66715-6922 66715-5506 66715692204 66715550604 2a91d0c9-4de2-fc80-e063-6294a90a6cb9 d18e1631-de43-4b29-e053-2995a90af56d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

